Impact of Kangroo on NeonatesNCT07548229
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
A study testing kangroo mother care and routine incubation care in people with Impact of Kangroo on Neonates, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the impact of kangaroo mother care on energy utilization in preterm neonates by measuring urinary levels of xanthine, uric acid, and malondialdehyde. It also aims to evaluate the effect of kangaroo mother care on physiological stress parameters in preterm neonates, as well as maternal… Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Impact of Kangroo on Neonates
- What is being tested?
- kangroo mother care and routine incubation care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm neonates (32-36 weeks)
- Vitally stable
- On room air or low ventilatory support
Who cannot join
- Neonates requiring surgery
- Intraventricular hemorrhage
- Receiving sedatives (morphine, fentanyl, midazolam)
- Renal impairment
- Congenital anomalies
- Cyanotic heart disease
Show all 10Show fewer
- Severe respiratory distress
- Hemodynamic instability
- Hypothermia
- Parental refusal
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the impact of kangaroo mother care on energy utilization in preterm neonates by measuring urinary levels of xanthine, uric acid, and malondialdehyde.
It also aims to evaluate the effect of kangaroo mother care on physiological stress parameters in preterm neonates, as well as maternal emotional status
Read the detailed description
This randomized controlled clinical trial aims to evaluate the effect of kangaroo mother care on energy utilization and oxidative stress in preterm neonates admitted to the neonatal intensive care unit (NICU) at Ain Shams University Children's Hospital, Cairo, Egypt.
Preterm neonates with gestational age between 32 and 36 weeks who meet the eligibility criteria will be enrolled and randomly assigned into two groups: an intervention group receiving kangaroo mother care and a control group receiving routine incubator care.
All enrolled neonates will receive routine incubator care until day 3 of life. On day 3, the intervention group will receive one hour of kangaroo mother care provided by the mother after feeding, while the control group will receive one hour of standard nursing care without kangaroo mother care.
Physiological parameters, including heart rate, respiratory rate, oxygen saturation, and temperature, will be monitored at baseline and every 15 minutes during the intervention period.
Urine samples will be collected from neonates 3 hours before and 3 hours after the intervention to measure biomarkers of energy utilization (xanthine and uric acid) and oxidative stress (malondialdehyde) using ELISA kits.
Maternal emotional status will be assessed before and after the intervention period.
The study is conducted following approval from the Research Ethics Committee of Ain Shams University, and informed consent will be obtained from parents or legal guardians prior to participation.
- Conditions
- Impact of Kangroo on Neonates
- Being tested
- kangroo mother care, routine incubation care
- Keywords
- kangroo, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kangroo mother careBehavioural
- All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care.
- The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding.
- The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding.
routine incubation careBehavioural
- All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care.
- The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding.
- The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | babies at day 3 will have kangro mother care Receives: Behavioral: kangroo mother care |
| control group | Placebo comparator | will have routine incubator care Receives: Behavioral: routine incubation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary biomarkers of energy utilization
Urinary xanthine and uric acid levels measured using ELISA kits.
Measured: 3 hours before and 3 hours after intervention on day 3 of life
Oxidative stress marker
Urinary malondialdehyde level measured using ELISA kits.
Measured: 3 hours before and 3 hours after intervention on day 3 of life
heart rate
Heart rate measured using standard neonatal monitoring devices.
Measured: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Respiratory rate
Respiratory rate measured using standard neonatal monitoring devices.
Measured: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
temperature
Body temperature measured using standard neonatal monitoring devices.
Measured: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Secondary outcomes (1)
maternal emotional status
It will be assessed by validated Arabic questionnaire
Measured: : 3 hours before and 3 hours after intervention on day 3 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 May 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impact of Kangroo on NeonatesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Amin Abd Elhamid, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548229
- Sponsor's protocol ID
- medicine Ain Shams
- Status last verified
- Jul 2026
- First submitted
- 16 Jan 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morelius E, Ortenstrand A, Theodorsson E, Frostell A. OC09 - Early maternal contact has an impact on preterm infants' brain systems that manage stress. Nurs Child Young People. 2016 May 9;28(4):62-3. doi: 10.7748/ncyp.28.4.62.s40.
PubMed 27214423
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07548229
- Acronym / sponsor ID
- medicine Ain Shams
- Conditions
- Impact of Kangroo on Neonates
- Keywords
- kangroo, neonates
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the impact of kangaroo mother care on energy utilization in preterm neonates by measuring urinary levels of xanthine, uric acid, and malondialdehyde.
It also aims to evaluate the effect of kangaroo mother care on physiological stress parameters in preterm neonates, as well as maternal emotional status
Detailed description
This randomized controlled clinical trial aims to evaluate the effect of kangaroo mother care on energy utilization and oxidative stress in preterm neonates admitted to the neonatal intensive care unit (NICU) at Ain Shams University Children's Hospital, Cairo, Egypt.
Preterm neonates with gestational age between 32 and 36 weeks who meet the eligibility criteria will be enrolled and randomly assigned into two groups: an intervention group receiving kangaroo mother care and a control group receiving routine incubator care.
All enrolled neonates will receive routine incubator care until day 3 of life. On day 3, the intervention group will receive one hour of kangaroo mother care provided by the mother after feeding, while the control group will receive one hour of standard nursing care without kangaroo mother care.
Physiological parameters, including heart rate, respiratory rate, oxygen saturation, and temperature, will be monitored at baseline and every 15 minutes during the intervention period.
Urine samples will be collected from neonates 3 hours before and 3 hours after the intervention to measure biomarkers of energy utilization (xanthine and uric acid) and oxidative stress (malondialdehyde) using ELISA kits.
Maternal emotional status will be assessed before and after the intervention period.
The study is conducted following approval from the Research Ethics Committee of Ain Shams University, and informed consent will be obtained from parents or legal guardians prior to participation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: kangroo mother carebabies at day 3 will have kangro mother care |
| control group | Placebo comparator | Behavioral: routine incubation carewill have routine incubator care |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonates (32-36 weeks)
- Vitally stable
- On room air or low ventilatory support
Key exclusion criteria (10 listed)
- Neonates requiring surgery
- Intraventricular hemorrhage
- Receiving sedatives (morphine, fentanyl, midazolam)
- Renal impairment
- Congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kangroo mother careo All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care. o The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding. o The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding. | Behavioural | study group |
| routine incubation careo All the preterm neonates will receive routine incubator neonatal care till day 3 of life. Then they will be subjected to the intervention according to the group; intervention group will undergo kangaroo mother care and control group without kangaroo mother care. o The neonates in the intervention group will be given 1 hour of kangaroo mother care by their own mothers once on day 3 of life after feeding. o The neonates in the control group will be given 1 hour of regular nursing care without kangaroo mother care once on day 3 of life after feeding. | Behavioural | control group |
Primary outcome
Urinary biomarkers of energy utilization
Time frame: 3 hours before and 3 hours after intervention on day 3 of life
Urinary xanthine and uric acid levels measured using ELISA kits.
Oxidative stress marker
Time frame: 3 hours before and 3 hours after intervention on day 3 of life
Urinary malondialdehyde level measured using ELISA kits.
heart rate
Time frame: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Heart rate measured using standard neonatal monitoring devices.
Respiratory rate
Time frame: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Respiratory rate measured using standard neonatal monitoring devices.
temperature
Time frame: Baseline and every 15 minutes during 1 hour intervention on day 3 of life
Body temperature measured using standard neonatal monitoring devices.
1 secondary outcome
maternal emotional status
Time frame: : 3 hours before and 3 hours after intervention on day 3 of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 27214423Morelius E, Ortenstrand A, Theodorsson E, Frostell A. OC09 - Early maternal contact has an impact on preterm infants' brain systems that manage stress. Nurs Child Young People. 2016 May 9;28(4):62-3. doi: 10.7748/ncyp.28.4.62.s40.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kangroo mother care and routine incubation care in people with Impact of Kangroo on Neonates, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary biomarkers of energy utilization (time frame: 3 hours before and 3 hours after intervention on day 3 of life). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07548229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.